American Dade - FDA 510(k) Cleared Devices
149
Total
149
Cleared
0
Denied
83 devices
Cleared
Nov 14, 1983
PARAMAX BILIRUBIN CALIBRATORS
Chemistry
94d
Cleared
Oct 28, 1983
PARAMAX SALICYLATE REAGENT
Chemistry
77d
Cleared
Oct 14, 1983
PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS
Chemistry
63d
Cleared
Oct 14, 1983
PARAMAX & GLUTAMYTRANSFERASE REAGENT
Chemistry
63d
Cleared
Oct 14, 1983
PARAMAX PHOSPHORUS REAGENT
Chemistry
63d
Cleared
Oct 14, 1983
PARAMAX TOTAL BILIRUBIN REAGENT
Chemistry
63d
Cleared
Sep 12, 1983
STRATUS CARBAMAZEPINE FLUROMETRIC
Chemistry
49d
Cleared
Aug 31, 1983
STRATUS AMIKACIN FLUOROMETRIC
Chemistry
44d
Cleared
Aug 31, 1983
STRATUS GENTAMICIN FLUOROMETRIC ENZYM
Chemistry
37d
Cleared
Aug 26, 1983
STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM
Chemistry
36d
Cleared
Aug 10, 1983
AQUEOUS BLOOD GAS CONTROL LEVEL I,II &
Chemistry
49d
Cleared
Jun 22, 1983
PARAMAX ALKALINE PHOSPHATASE REAGENT-
Chemistry
44d
Cleared
Jun 22, 1983
PARAMAX CREATINE KINASE REAGENT
Chemistry
44d
Cleared
Jun 17, 1983
PARAMAX AMALINE REAGENT
Chemistry
39d
Cleared
Jun 08, 1983
PROTOTRO/PROTEOLYTIC ENZYME CONTROL
Chemistry
48d
Cleared
Mar 07, 1983
PARAMAX ANALYTICAL SYS
Chemistry
35d
Cleared
Feb 07, 1983
IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS
Chemistry
90d
Cleared
Nov 16, 1982
QAP MICROCOMPUTER SYSTEM
Chemistry
26d
Cleared
Oct 27, 1982
MONI-TRO ES CHEMISTRY CONTROL LEVEL IX
Chemistry
34d
Cleared
Aug 25, 1982
DISPOSABLE DISPENSING-SPREAD PIPETS
Chemistry
23d
Cleared
Aug 05, 1982
DADE CHILL TRAY
Chemistry
16d
Cleared
Jul 27, 1982
DADE DISP. DISPENSING-SPREADING PIPETS
Chemistry
12d
Cleared
May 14, 1982
STRATUS TDM CONTROL, LEVELS I,II,III
Chemistry
99d
Cleared
Jan 28, 1982
TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY
Chemistry
21d
Cleared
Dec 31, 1981
DADE COLORIMETRIC AMYLASE
Chemistry
14d
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